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Francine Kaufman Transcript

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Steve: This is Steve Freed with Diabetes in Control and we are here at the American Diabetes Association 77th scientific session 2017, and we are here to present you with some really exciting interview with some of top endos from all across the world. We have a very special guest, Dr. Francine Kaufman who has a long history of being involved with diabetes, including being president of the American Diabetes Association.

Dr. Kaufman: That’s true. In 2003.

Steve: Maybe we can start off and tell us a little bit of what do, because you’ve done many different things.

Dr. Kaufman: Well, I am a pediatric endocrinologist, and I went on staff at Children’s Hospital in Los Angeles, which is part of the University of Southern California in 1980, and I’ve been there 4 years before for my training, including my pediatric endocrine fellowship, and I was the head of the division for a decade or so, and in 2009, I became the Chief Medical Officer at Medtronic Diabetes.

Steve: Talk a little bit about Medtronic and their new breakthrough in diabetes, that’s the new pump. There is a little bit of confusion about that, that is not truly an artificial pancreas, but everybody keeps calling it an artificial pancreas, maybe you can explain what it actually is.

Dr. Kaufman: The goal from quiet some time, and maybe the original dream was Al Mann’s when he started MiniMed. And when Medtronic bought MiniMed in 2000, they bought the building, the pumps, the sensors and Al’s dream, so the goal has always been to take that marriage of the pump and the sensor, and automate aspects of insulin delivery, so the patient has less burden in managing diabetes, and hopefully the outcomes are actually better, since for the most part machine can do a pretty good job of flying planes, controlling temperature, maybe even having self-driving cars. So, at Medtronic, the goal was to go incremental, and it has all been put in the category of artificial pancreas, which just means automating insulin delivery. And that category means that the patient is not in total control of insulin delivery, which makes it kind of an “artificial pancreas.” But I think when most of us think about artificial pancreas, we think that the device will control all insulin delivery, and these first iterations, all the way to our MiniMed 670G system, are not complete automation of insulin delivery. So, the 670 G system automates basal insulin, so there’s no basal rates that are preset anymore that operate when somebody is in what we’re going to call auto mode, which means the algorithm every 5 minutes determines how much basal insulin to give, is a little stroke. And instead of 5 minutes, it may be to a maximal amount that’s determined by the algorithm and adapted every day, or it may be actually no insulin for a while day if the glucose values are either low or falling. So, that automation of insulin delivery done by the algorithm, done by the pump and sensor is married to now the delivery of bolus insulin, for meals by the patient. The patients determine how many carbohydrates they are going to eat, they enter that in the bolus wizard, the pump then gives them their bolus for their meal. And for correction dose, if the glucose value is elevated, the pump will do the calculations but ask the patient to confirm. So, it’s kind of autopilot and a co-pilot depending what’s going on, but it is much more automation than we’ve ever seen, and as result we’ve shown with our pivotal trial, it’s both safe and actually resulted in lower A1C and more time in the target range for more patients.

Steve: So, let me ask you a question. You leave here and you call over and a car pulls up, there is no driver in it…

Dr. Kaufman: Well, so far, there’s still a driver. But one day there won’t be.

Steve: We’re just talking about a couple of years from today. There’s no driver and a voice comes up and it says, “I’m your driver and even though you can’t see me, tell me where you want to go and I’ll take you there and you look very nice today.” Would you get in that cab?

Dr. Kaufman: Well, I might not get into the very first cab ever driving, but at some point, after a pivotal trial and an FDA equivalent approval, I probably would get it, because it will be efficient, it would enable me not to drive myself and it will get me where I’m going.

Steve: But we all know that electronic, mechanics, there’s no such thing as perfection.

Dr. Kaufman: There is not such a thing as perfection with people either. There’s a lot of car accidents right now, and that’s with people in control, and the concept is it will be fewer, but still some, with a controlled algorithm determining.

Steve: So, that’s what you would tell people when, let’s say, you get to the next level where is completely automated, works on the amount of insulin, the amount of food that you have, it’s completely automatic, it still it isn’t what you would call a cure.

Dr. Kaufman: No.

Steve: But certainly people will have a fear that something seriously could go wrong if there is a malfunction, and you are basically saying that it’s true with everything.

Dr. Kaufman: Yeah, It’s true now with a syringe, a vial of insulin or a pen or a pump. Somebody could make a mistake, put in the wrong dose of carbohydrates that they are going to ingest, put in a dose, forget to eat, so there is always, I would tell somebody that we should never have I fear of taking exogenous insulin, but we think the machine could do a good job, a better job, because it’s going to be working every 5 minutes that is all it’s doing where you as a person with diabetes have a lot of other things on your agenda. So nothing will be fail safe, well, it’s will fail safely, but it won’t, at all times, get you where you want to be and might have some episodes of hypoglycemia, but it will alarm and alert, and  if there is a real technical problem it will shut itself down an alarm like pumps do now.

Steve: So, I understand that you are releasing the new pump gradually, it’s not going out to everybody overnight. Where are you as far as it goes with your patient base?

Dr. Kaufman: So, we are announcing, as a matter of fact I think either today or tomorrow so by the time this is out it will already be announced, that we are now going to the rest of our Priority Access patients, so they bought our 630G system, they will be able to turn that in and get a 670G system. I think there’s an upfront of $299 and they can actually do some things to get that money back by answering surveys and uploading it to the Carelink, so if they wanted to, in the end, it would cost them $0 to upgrade. But there are 30,000 people who have signed up for that, so it’s going to take us awhile. We just finished what we cause a patient learning phase where we wanted to be sure the materials we’ve developed are adequate; we want to be sure we’ve got all the health care providers out there educated; our helpline is ready, new system, people are going to call a lot more. So, we saw that with 700 patients, we watched the data. The data is essentially week-to-week equivalent to what we have seen in our pivotal trial. So ready to go on with these other patients who’ve been waiting. We’re hoping that we’ll be done with that by maybe mid fall and then we’ll be ready for whoever else wants to buy the system after that.

Steve: Well, the whole concept is really based upon the sensor. It does what the sensor tells it to do. So, it’s really matter of having a really high-quality sensor. Because I know sensors are not the easiest thing to develop and make and produce in mass scale. How do manage to get a high-quality sensor for every single patient?

Dr. Kaufman: So, we’re very committed to this. We have developed a new sensor. It looks like our sensor that’s on the market now but our new sensor, our Guardian Sensor 3, it’s not the same. It’s two generations from where we are now in the U.S., different chemistry, entirely different build, different assembly lines, and different substrates. So, we have spent a lot of time perfecting the sensor. There’s a new specialized chip in it that’s looking for sensors that are drifting and if it sees a drift or what would become an outlier, it asks for another calibration; we call it a Smart Cal. If it can be brought back, it will continue to run closed-loop. If it cannot, it will stop running closed loop, so there is that safety mechanism of his sensor self-diagnostics continuously looking for a sensor drift. Beyond that, we’ve done a pivotal trial. We’ve looked at the data from the use of 670 both in our pivotal, the pivotal sensor trial and now that use at home in the real world and the Mart is excellent with two to three calibrations a day. It’s exactly what we want to be, 10% or less. So, we feel very confident in the sensor. The people using it feel very confident as well and then we got that special chip. If it does start to not perform, it informs the individual and stops running closed-loop if it can’t fix itself.

Steve: We’ve gone to the moon, you guys sit around a table saying what are we going to do for the future of Medtronic. What kind of ideas have you discussed and where’s Medtronic going?

Dr. Kaufman: I think we haven’t solved all the problems of diabetes. This is pretty much a type 1 solution at this point and this is just the first step. We’ve got the next generation already on the drawing board. They’re very excited to team with the DreaMed group, with their fuzzy logic. So, the next generation algorithm will be, if you’d like it to be, a little bit more aggressive. So, we are excited about that, more automatic bolusing so that the patient is going to be asked to do less and less, and the device will do more and more. We are looking at the use with ultra-rapid-acting insulin to see how far that gets us down the line of not having to inform about an upcoming meal. So very excited about that pathway. I think we’re real clear we’re going to be working with the patient community a lot more than we ever have and we have all along this development pathway, so that we are sure we get the voice of what the patient really wants. Now, that’s for type 1, and at some point, we’ll have to see what the in-hospital solution is around automating insulin delivery as well. But for type 2 and kind of a services-and-solutions, we’re doing a lot. We have now three business units inside the overall diabetes umbrella. Our intensive insulin management that has the closed-loop device, our non-intensive for type 2, so we’re working on a disposable retrospective or professional CGM that will take no calibration at all. Very excited about offering that the patients. It will be attached to a decision-support algorithm that we think will make a big difference for providers, particular primary care providers who are giving most of the care. Then on the diabetes services and solutions, we’re looking to give a lot more solutions through what we’re releasing very soon – we just released in Europe, hopefully in the U.S. pretty soon – a stand-alone sensor and straight to the cell phone. Along with it you’ll be able to get an app that we’ve been collaborating with IBM to have advanced analytics, really big data learning, machine learning, so that patients can start to understand their patterns and trends; see where there might be a problem with their overall management, including a big nutritional component if that’s what they’d like. We’re looking at other solutions like Canary Health for the prediabetes space. We’re looking at clinics in the Netherlands that were very involved in delivering care. So, we’re really, I think, expanding our portfolio to meet the needs of the different populations of diabetes.

Steve: I understand that Dexcom is a competitor of the sensors. They announced, I think they’ve already done it, they’re working with Apple so that the reading shows up on the Apple watch, and you had just mentioned that. How far away are you from that?

Dr. Kaufman: Well, we’ve got lots of partners, and some are very tied relationships, some are a looser. I think the kind of consumer-based companies are very interested in getting in the diabetes space. We’re talking to quite a number of them, IBM, Samsung, a lot of different opportunities, and we’ll look to partner with whoever can help us make a difference for people with diabetes.

Steve: I’ve been reading a lot about Medtronic. Only like 80% of the pump market and your competitors are slowly dwindling away. I remember Deltec and they’re gone. It really boils down to, there’s only so many type 1 patients and that means it can only support so many pump companies. Medtronic is only at the market pretty much from day one. I guess even when Al Mann was around.

Dr. Kaufman: Well, it was Al who owned the market originally. He was the only one in it when he first developed it.

Steve: Obviously Medtronic is in a good position right now and from what you’re saying, you’re developing things that is going to keep you in that position for a long time.

Dr. Kaufman: Our focus is really helping people with diabetes, so we would like to get behind just the pump and the sensor and even get beyond, obviously, the automation of insulin delivery, to expand to a broader population of people with diabetes, to broader needs. Looking at more unmet needs that we’ve had in the past. We’ve worked very hard to be a responsible partner with people with diabetes, people and their healthcare providers. We have a vast network of clinicians that we’ve helped train. We have a lot of support through our helpline. It does take a village for a lot of people to use diabetes technology. Maybe that it will get easier as time goes on. I think part of our success has been not only innovating and continuing to push the envelope on the devices themselves but really partnering with the patient population and offering the services that they need, the support that they need, the education that they need.

Steve: How important is customer service?

Dr. Kaufman: Well, I would tell you that the most important thing is customer service. It’s getting to understand what the patient problem is, being sure that we can answer, help them solve those problems. Some of them are very idiosyncratic, some of them are very broad-based across the larger population. I think the voice of the customer where the customer comes first…I’ve really been there not even that long, but I would tell you that we have become a patient-at-the center company. It’s been a migration, it’s been a change. It was a company started, when Al started it, an engineer-at-the-center, an engineer trying to solve the problems, and they did a great job, but that’s not the world anymore. The voice of the customer, the patient ability to giet information, the patient on the web communicating Patient to Patient, that’s what we’re really interested in. How can we help in that arena? How can we answer broader issues for people and how can we make their voices really part of our solutions?

Steve: being here at ADA, what do you think is going to be the most exciting thing coming out of this meeting?

Dr. Kaufman: I can’t even tell you how many ADAs I’ve been at. They’re all exciting. They all have something new. For me, the most wonderful part is seeing old friends and all the networking that goes on, but I think there’s a lot of exciting in the Pharma Arena obviously in the type 2 space as well as the type 1 space, but there’s no doubt that there’s a lot about diabetes technology and I think for me, as part of Medtronic, that’s the most exciting.

Steve: I want to thank you for your time. It’s very interesting.

Dr. Kaufman: Thank you.